Department of Medicine, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York, USA.
J Cardiovasc Electrophysiol. 2021 Mar;32(3):565-567. doi: 10.1111/jce.14935. Epub 2021 Feb 15.
The EMBLEM subcutaneous implantable cardioverter defibrillator (S-ICD) has an expected longevity of 7 years. In August 2019, Boston Scientific released an advisory regarding a limited subset of ~400 S-ICDs that exhibited an increased likelihood of an electrical component malfunction causing accelerated battery depletion. We observed several cases of nonadvisory S-ICD early battery depletion and sought to systematically evaluate the cohort of EMBLEM devices implanted and followed in our medical center. Out of 118 nonadvisory EMBLEM S-ICDs with a median time to most recent follow-up after implant of 735 days (interquartile range 375-1219 days), there were four premature battery failures identified. Serial device interrogations showed a sudden reduction in battery life at 1 195, 1 205, 1 300, and 678 days after implant. The number of shocks delivered during the lifetime of the devices did not explain the premature depletion. There was a sudden departure from the gradual linear decrease in battery longevity observed over time. We are the first to report a signal of premature battery depletion among S-ICD EMBLEM devices that were not among the initial advisory devices. The prevalence of premature battery failure in our cohort was 3.4%, occurring at an average of 1 095 days. Following these reports, Boston Scientific issued an advisory on EMBLEM devices in December 2020 extending beyond the initial advisory subset. The current projected occurrence rate for hydrogen-induced accelerated battery depletion is 3.7% at 5 years. Increased surveillance of this potential device issue and mitigation to identify patients at risk for this is warranted.
EMBLEM 皮下植入式心律转复除颤器(S-ICD)的预期寿命为 7 年。2019 年 8 月,波士顿科学公司发布了一项关于约 400 台 S-ICD 的咨询公告,这些设备存在电气元件故障的风险,可能导致电池加速耗尽。我们观察到几例未经咨询的 S-ICD 早期电池耗尽的情况,并试图系统地评估我们医疗中心植入和随访的 EMBLEM 设备队列。在 118 例未经咨询的 EMBLEM S-ICD 中,中位植入后最近随访时间为 735 天(四分位距 375-1219 天),发现有 4 例电池提前失效。连续的设备检测显示,在植入后 1195、1205、1300 和 678 天,电池寿命突然减少。设备寿命期间的电击次数并不能解释电池的过早耗尽。电池寿命的逐渐线性下降出现了突然偏离。我们是第一个报告 EMBLEM S-ICD 设备中存在电池提前耗尽信号的人,这些设备不在最初的咨询设备之列。我们队列中提前电池故障的发生率为 3.4%,平均发生在 1095 天。在这些报告之后,波士顿科学公司于 2020 年 12 月发布了一项关于 EMBLEM 设备的咨询公告,超出了最初的咨询设备范围。目前,预计在 5 年内,氢诱导加速电池耗尽的发生率为 3.7%。需要加强对此潜在设备问题的监测,并采取措施识别有风险的患者。